Pharmaceutical Regulatory Affairs

Pharmaceutical Regulatory Affairs is a department in a pharmaceutical company that ensures that its organization complies with all of the regulations and laws pertaining to drug research and development companies. This department works with federal, state and local regulatory agencies on issues affecting drug research and development.

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Pharmaceutical Regulatory Affairs and MasterControl

Pharmaceutical Regulatory Affairs is a department of a pharmaceutical company dedicated to ensuring the safety of a company's pharmaceutical products. In the United States, these departments are governed by rules issued by the U.S. Food and Drug Administration.

The Pharmaceutical Regulatory Affairs department is responsible for ensuring that a company's drug promotion is not false or misleading and that the complete picture of a drug is given to the public. There is a Code of Federal Regulations (CFR) that employees in this area must follow. The significant areas of this code include:

  • 201 Prescription Drug Labeling
  • 202 Prescription Drug Advertising

The FDA also issues guidance's for these departments to follow. The guidance's describe the FDA's current thinking on a topic.

With more than a decade of experience in the rigorous FDA and ISO environments, MasterControl has developed an integrated software solution that combines industry best practices with the flexibility to meet the needs of every Pharmaceutical Regulatory Affairs department.

The MasterControl™ quality management suite consists of configurable, easy-to-use, and connected applications for automating, streamlining, and effectively managing document control, change control, training control, audits, corrective/preventive action (CAPA), customer complaints, and other documents- and forms-based quality and business processes under a single Web-based platform. Hundreds of companies worldwide rely on MasterControl to facilitate compliance with FDA regulations (e.g., 21 CFR Parts 11, 210-211, 820, 606), ISO quality standards (e.g., ISO 9000, ISO 13485, ISO 14000, ISO/TS16949), pharmaceutical regulatory affairs and Sarbanes-Oxley Act requirements.

About MasterControl Pharmaceutical Regulatory Affairs

MasterControl Inc. is a global provider of GxP process and document management software solutions for life science companies. The MasterControl suite is easy to use, easy to deploy, easy to validate, and easy to maintain. It incorporates industry best practices for automating and connecting every stage of the product development cycle, while facilitating regulatory compliance and managing pharmaceutical regulatory affairs. By combining an integrated platform with a continuum of risk-based software validation products and services, MasterControl drives down the total cost of ownership and enables customers to extend their investment across the enterprise. Hundreds of companies worldwide take help from MasterControl's pharmaceutical regulatory affairs for easier compliance, faster validation, and better process management. For more information, visit, or call 800-825-9117.

To learn more about MasterControl and Pharmaceutical Regulatory Affairs, visit MasterControl's Resource Center. The Resource Center offers industry white papers, product data sheets, Q & As, case studies and webinars which provide extensive information for companies seeking new tools for change management.